Plazomicin

What is Plazomicin?

Fig.1: Plazomin Structure

Plazomicin is an aminoglycoside antibiotic.

What are the uses of this medicine?

Plazomicin is an antibiotic that is used to treat complicated urinary tract infections that cannot be treated with a safer antibiotic.

How does this medicine work?

Plazomicin decreases the ability of the bacteria responsible for the infection from making protein.

Who Should Not Use this medicine?

Pregnant women and children should not use this medicine.

You should not use plazomicin if you are allergic to plazomicin or similar antibiotics such as: amikacin, gentamicin, kanamycin, neomycin, paromomycin, streptomycin, or tobramycin.

Is this medicine FDA approved?

Zemdri (Plazomicin) has received FDA approval on 07/27/2018.

How should this medicine be used?

Plazomicin is administered by intravenous (IV) infusions. A healthcare provider should administer your first dose and teach you how to properly use the medicine yourself. Do not use if you do not understand all the instruction and consult a doctor or pharmacist.

Drink plenty of liquids while you are using plazomicin.

You may need frequent blood or urine tests. Your hearing, kidney function, and nerve function may also need to be checked while using this medicine.

What are the  dosage forms and brand names of this medicine?

The brand name of this medicine is Zemdri.

The dosage varies depending on the the type of infection with additional adjustments depending on any other health conditions the patient may have. Therefore, it is important to consult your doctor when deciding on this medication. The general dosage of Zemdri for a complicated urinary tract infection, including Pyelonephritis, is 15 mg/kg administered every 24 hours for 4-7 days by intravenous (IV) infusion over 30 minutes in patients 18 years of age or older and with creatinine clearance (CLcr) greater than or equal to 90 mL/min.

What side effects can this medication cause?

Plazomicin can harm your kidneys, and may also cause nerve damage or hearing loss.

Common side effects may include:

• nausea, vomiting, diarrhea;
• headache; or
• feeling light-headed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. Side effects can be reported to FDA at 1-800-FDA-1088.

Serious side effects may be more likely to occur in older adults. Call your doctor if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
• dizziness, spinning sensation;
• a light-headed feeling, like you might pass out;
• hearing loss, a buzzing or roaring sound in your ears (during or after treatment with Zemdri);
• muscle weakness; or
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

What special precautions should I follow?

Tell your doctor if you have ever had:

• kidney disease; or
• nerve-muscle disorder such as myasthenia gravis.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

Safety has not been established for pregnancy. However, it is recommended that Plazomicin is used during pregnancy.

Can this medicine be used in children?

The safety and effectiveness of ZEMDRI in patients less than 18 years of age have not been established.

What should I know about storage and disposal of this medication?

Store in the refrigerator and do not freeze. Each bottle is for one use only, and must be thrown away even there is still medicine left inside. Use a needle and syringe only once. When disposing of the needle and syringe, place them in a puncture-proof "sharps" container, and follow local laws on disposing of this container.

• Dailymed label info on Plazomicin
• FDA Plazomicin